BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX GENERAL ANESTHESIA CIRCUITS

    MDR report key: 24403397 · Received February 20, 2026

    Report

    Report Number
    3012307300-2026-01544
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    September 1, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ICU MEDICAL S.A. DE C.V.
    Product Code
    CAI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA MACHINE CIRCUIT HAD HOLES IN THE TUBING. PER REPORTER, THE ANESTHESIA CIRCUIT WAS FUNCTIONING THROUGH ENTIRE CASE UNTIL TIME FOR EXTUBATION. REPORTER STATED ANESTHESIA WAS UNABLE TO FULLY VENTILATE OR GET END-TIDAL CARBON DIOXIDE AND THE HOLE IN THE DEVICE WAS ABLE TO BE HEARD BY THE USER. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466574 PORTEX GENERAL ANESTHESIA CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI ICU MEDICAL S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown